National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 58622 [2017-26799]
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Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
collection of information to OMB for
review and clearance.
Data To Support Drug Product
Communications as Used by the Food
and Drug Administration
OMB Control Number 0910–0695—
Extension
This information collection supports
Agency outreach efforts. Testing of
communication messages in advance of
a communication campaign provides an
important role in improving FDA
communications as they allow for an indepth understanding of individuals’
attitudes, beliefs, motivations, and
feelings. The methods to be employed
include individual in-depth interviews,
general public focus group interviews,
intercept interviews, self-administered
surveys, gatekeeper surveys, and
professional clinician focus group
interviews, all on a voluntary basis. The
methods to be used serve the narrowly
defined need for direct and informal
opinion on a specific topic and, as a
qualitative research tool, have two major
purposes: To obtain information that is
useful for developing variables and
measures for formulating the basic
objectives of risk communication
campaigns, and to assess the potential
effectiveness of messages and materials
in reaching and successfully
communicating with their intended
audiences.
FDA will use these methods to test
and refine its ideas and to help develop
messages and other communications but
will generally conduct further research
before making important decisions, such
as adopting new policies and allocating
or redirecting significant resources to
support these policies. FDA will use
this mechanism to test messages about
regulated drug products on a variety of
subjects related to consumer, patient, or
health care professional perceptions and
about use of drug products and related
materials, including but not limited to,
direct-to-consumer prescription drug
promotion, physician labeling of
prescription drugs, medication guides,
over-the-counter drug labeling,
emerging risk communications, patient
labeling, online sale of medical
products, and consumer and
professional education. Annually, FDA
projects about 45 communication
studies using the variety of test methods
listed in this document. FDA is
requesting an extension of these burden
hours so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
In the Federal Register of June 19,
2017 (82 FR 27840), we published a 60-
day notice requesting public comment
on the proposed extension of the
collection of information. One comment
was received requesting that FDA
publish an annual list of its planned
drug product communication studies
and strive to reflect an overall work
plan. The comment also noted the rather
broad topic areas included in the
information collection and suggested
that perhaps additional notice regarding
individual studies would allow for more
meaningful feedback on whether that
particular study would be necessary.
FDA appreciates this comment. In
determining which drug product
communications it will undertake, we
first consider those we believe will best
address current or immediate public
health issues. We also note that, in
accordance with the PRA, any proposed
study under this information collection
request must first be submitted to and
approved by OMB to determine whether
it falls within the scope of the
collection. At the same time, as
resources are available, we will make
every effort to communicate to our
stakeholders anticipated studies so that
ongoing or related research can be
coordinated.
We therefore estimate the burden of
this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Interviews/Surveys .....................................................
1 There
19,822
Average
burden per
response
(in hours)
Total annual
responses
1
19,822
0.24 (14 minutes) ....
Total hours
4,757
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2017–26795 Filed 12–12–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
sradovich on DSK3GMQ082PROD with NOTICES
Number of
responses per
respondent
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
VerDate Sep<11>2014
18:53 Dec 12, 2017
Jkt 244001
Program, Division of Extramural Activities,
Room 3G62A, National Institute of Health,
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20899–823, (240) 669–5081,
ecohen@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01).
Date: January 17, 2018.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Eleazar Cohen, Ph.D.,
Scientific Review Officer, Scientific Review
Dated: December 6, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
PO 00000
Frm 00035
Fmt 4703
Sfmt 9990
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
[FR Doc. 2017–26799 Filed 12–12–17; 8:45 am]
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[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Page 58622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26799]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01).
Date: January 17, 2018.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 5601 Fishers Lane,
Rockville, MD 20892, (Telephone Conference Call).
Contact Person: Eleazar Cohen, Ph.D., Scientific Review Officer,
Scientific Review Program, Division of Extramural Activities, Room
3G62A, National Institute of Health, NIAID, 5601 Fishers Lane, MSC
9823, Bethesda, MD 20899-823, (240) 669-5081, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: December 6, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-26799 Filed 12-12-17; 8:45 am]
BILLING CODE 4140-01-P
